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Suspending agent effects on steroid suspension dissolution profiles.

S A Howard, J Mauger, J W Hsieh

    Journal of Pharmaceutical Sciences
    |December 1, 1979
    PubMed
    Summary
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    Lot-to-lot variations in prednisolone acetate dissolution rates were linked to particle size. Suspending agents like carboxymethylcellulose sodium and hydroxypropyl methylcellulose affected dissolution and particle aggregation, impacting suspension formulation.

    Area of Science:

    • Pharmaceutical Sciences
    • Materials Science

    Background:

    • Prednisolone acetate is a widely used corticosteroid in various pharmaceutical suspensions.
    • Understanding factors influencing its dissolution rate is crucial for effective drug delivery and formulation stability.

    Purpose of the Study:

    • To investigate lot-to-lot variations in prednisolone acetate dissolution.
    • To evaluate the impact of common suspending agents on dissolution profiles and particle-size distributions.
    • To understand the implications of these variations on suspension formulation.

    Main Methods:

    • Dissolution profiling of two prednisolone acetate lots.
    • Particle-size analysis of the drug substance.
    • Investigation of suspending agents: carboxymethylcellulose sodium and hydroxypropyl methylcellulose.

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  • Assessment of particle aggregation in suspensions.

    • Main Results:

    • Significant lot-to-lot variation in prednisolone acetate dissolution rates was observed, correlated with the percentage of fine particles.
    • Carboxymethylcellulose sodium inhibited dissolution in one lot, potentially due to fine particle aggregation.
    • Hydroxypropyl methylcellulose inhibited dissolution in both lots, with or without observable particle aggregation.

    Conclusions:

    • Particle-size distribution is a critical factor influencing prednisolone acetate dissolution rates.
    • Suspending agents can differentially affect prednisolone acetate dissolution and particle characteristics.
    • These findings highlight the importance of controlling raw material properties and selecting appropriate suspending agents for consistent suspension formulation.